Rare Bone DisordersPaS2-EXTENDNCT07102875
Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases
A study testing Sailing Intervention Plus Home-Based Telerehabilitation and Home-Based Telerehabilitation in people with Rare Bone Disorders, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
"Ready to Sail 2 - EXTEND" is a pilot randomized interventional trial designed to assess the feasibility, safety, and preliminary impact of an innovative rehabilitation model combining sailing therapy (velatherapy) with a remote telerehabilitation maintenance program in young individuals with rare skeletal disorders. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Rare Bone Disorders
- What is being tested?
- Sailing Intervention Plus Home-Based Telerehabilitation and Home-Based Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals aged 12 to 30 years, of any sex
- Clinical and/or molecular genetic diagnosis of RSD per Orphanet classification
- No orthopedic surgery within the past 6 months, unless deemed clinically irrelevant to study participation by the investigator
- Ability to understand and comply with study procedures
- Signed informed consent obtained from the participant or a legal guardian (for minors)
Who cannot join
- Severe or unstable medical conditions that could interfere with participation (e.g., uncontrolled cardiac or respiratory disease)
- Cognitive or neurological impairments that may hinder adherence to the study protocol
- Participation in similar intensive rehabilitation programs within the past 3 months
- Contraindications to virtual or sailing-based activities, including but not limited to: (a) Severe motion sickness; (b) Vertigo or vestibular disorders; (c) Photosensitive epilepsy
- Musculoskeletal injuries (e.g., fractures or major sprains) occurring within the past 12 months
- Any condition or circumstance that, in the opinion of the investigator, may compromise safety or study compliance
- Decline or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study "Ready to Sail 2": Evaluation of the Feasibility and Safety of Sail-Assisted Telerehabilitation in Patients With Rare Skeletal Diseases - Assessment of Motor, Psychosocial, and Quality of Life Outcomes
"Ready to Sail 2 - EXTEND" is a pilot randomized interventional trial designed to assess the feasibility, safety, and preliminary impact of an innovative rehabilitation model combining sailing therapy (velatherapy) with a remote telerehabilitation maintenance program in young individuals with rare skeletal disorders. Building on the promising results of the previous Ready to Sail feasibility study (NCT06397443), this study aims to validate and compare two rehabilitative approaches.
A total of 24 patients aged 12-30 years with a confirmed diagnosis of a rare skeletal disorder will be randomly assigned (1:1) to either:
Read more
- Group 1 (Experimental): a 5-day intensive sailing therapy intervention followed by a 3-month personalized telerehabilitation program at home; or
- Group 2 (Active Control): a 3-month telerehabilitation-only program with identical frequency and progression.
The primary objective is to evaluate the feasibility of the experimental program, in terms of adherence, acceptability, and safety. Secondary outcomes include motor functionality (measured by inertial sensors), psychosocial well-being (assessed through validated PROMs), health-related quality of life, and pain perception. The study also explores the medium-term sustainability of rehabilitation outcomes and the influence of individual variables (e.g., age, gender, disease subtype).
The intervention is delivered through a multidisciplinary, patient-centered approach involving rare disease experts, physiatrists, biomechanical engineers, and partner sailing organizations. Sail training activities are adapted for safety and inclusion, and are conducted in two coastal settings (Marina di Ravenna and Palermo), ensuring geographical balance for participant accessibility.
This trial seeks to strengthen the evidence base for integrated, inclusive, and scalable rehabilitation models that address both motor and psychosocial dimensions in rare skeletal conditions.
- Conditions
- Rare Bone Disorders
- Being tested
- Sailing Intervention Plus Home-Based Telerehabilitation, Home-Based Telerehabilitation
- Keywords
- Rare Diseases, Musculoskeletal Diseases, Telerehabilitation, Physical Therapy Modalities, Games, Recreational, Quality of Life, Feasibility Study, Social Behavior, Psychological Well-Being, Adolescent, Young Adult, Wearable Devices, Biomechanical Movement Capture
- Medical subject headings
- Rare Diseases, Musculoskeletal Diseases, Social Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sailing Intervention Plus Home-Based TelerehabilitationBehavioural
Also called 5-day sailing activity
A two-phase rehabilitation program combining 5 days of intensive sailing therapy with a 3-month home-based telerehabilitation plan. The sailing component includes group-based activities in adapted sailing environments, conducted in Marina di Ravenna or Palermo, with daily debriefing and psychosocial support. The telerehabilitation component includes twice-weekly supervised sessions delivered via a digital platform, focusing on progressive motor, proprioceptive, and postural exercises. The intervention aims to improve motor function, quality of life, and psychosocial well-being in individuals with rare skeletal disorders.
Home-Based TelerehabilitationBehavioural
Participants perform a 3-month home-based rehabilitation program consisting of two remote sessions per week via a supervised digital platform. Each session includes warm-up, strength and coordination exercises, and cool-down. Exercises are progressive and standardized, but adapted to individual needs to ensure safety and adherence. The intervention targets motor function, balance, proprioception, and psychosocial outcomes, without any sailing component. This arm serves as the active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Sailing Intervention Followed by Home-Based Telerehabilitation Program | Experimental | Participants assigned to this arm will receive a 5-day intensive sailing intervention program, followed by a 3-month home-based telerehabilitation program. The sailing includes daily group-based sailing activities and debriefing activities aimed at enhancing motor skills, coordination, and psychosocial well-being. After the sailing phase, participants will engage in remote physical therapy sessions twice a week via a supervised digital platform. The telerehabilitation component includes progressive exercises targeting balance, proprioception, and functional strength. Receives: Behavioral: Sailing Intervention Plus Home-Based Telerehabilitation |
| Home-Based Telerehabilitation Program | Active comparator | Participants in this arm will undergo a 3-month home-based telerehabilitation program. The intervention consists of two weekly remote sessions conducted via an accredited digital platform. Each session includes warm-up, structured motor and postural exercises, and cool-down/stretching phases. Exercises are progressive and tailored to individual functional capacities, with the goal of improving balance, coordination, and physical function. No sailing therapy is included in this arm. Receives: Behavioral: Home-Based Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Sailing and Home-Based Telerehabilitation
Defined as the percentage of scheduled sessions completed by each participant. Adherence is considered achieved if ≥75% of scheduled sessions are completed.
Unit of Measure: Percentage of participants meeting adherence threshold
Measured: At 6 months after baseline (end of intervention period)
Acceptability of the Intervention
Defined by recruitment rate ≥80% and dropout rate <20%. Unit of Measure: Recruitment rate (%), Dropout rate (%)
Measured: At 6 months after baseline (end of intervention period)
Safety of the Intervention
Defined as the absence of serious adverse events related to the intervention. Unit of Measure: Number of participants experiencing a serious adverse event
Measured: At 6 months after baseline (end of intervention period)
Secondary outcomes (6)
Change in Motor Function Measured by Inertial Measurement Units
Motor function will be assessed using wearable inertial measurement units (IMUs) to evaluate postural control, gait parameters, upper limb mobility, and proprioception. Data will be collected through standardized physical tasks and analyzed to detect changes over time.
Measured: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Health-Related Quality of Life Measured by EQ-5D-5L
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. This instrument includes:
- EQ-5D-5L Index Value, ranging from -0.232 to 1.000 (where 1.000 indicates full health, 0 indicates death-equivalent health, and negative values represent health states considered worse than death; higher scores indicate better health status).
- EQ Visual Analog Scale (EQ-VAS), ranging from 0 to 100, where 0 represents the "worst imaginable health state" and 100 represents the "best imaginable health state." Higher scores indicate better self-rated health.
Unit of Measure: EQ-5D-5L Index Value (-0.281 to 1.000); EQ-VAS Score (0 to 100)
Measured: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Psychosocial Functioning Measured by BESSI-45
Psychosocial functioning will be assessed using the Behavioral, Emotional, and Social Skills Inventory (BESSI-45). The BESSI-45 includes 45 items rated on a 5-point Likert scale (1 = "Not at all well" to 5 = "Extremely well"), covering five domains: Self-Management, Social Engagement, Cooperation, Emotional Resilience, and Innovation Skills. Total scores range from 45 to 225, with higher scores reflecting greater psychosocial skills and better psychosocial functioning.
Unit of Measure: BESSI-45 total score (range 45-225)
Measured: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Functional Outcomes Measured by PODCI
Functional health outcomes will be assessed using the Pediatric Outcomes Data Collection Instrument (PODCI), which includes domains such as upper extremity function, mobility, sports and physical activity, pain, happiness, and global function.
Measured: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-Pain), a 10-centimeter horizontal line anchored at the extremes with "0 = no pain" and "10 = worst pain imaginable." Participants mark their current pain level along the line, which is then measured in centimeters from the "no pain" anchor. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Unit of Measure: VAS-Pain score (0-10)
Measured: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Kinesiophobia Measured by Tampa Scale of Kinesiophobia (TSK)
Fear of movement will be assessed using the Tampa Scale of Kinesiophobia - 13-item version (TSK-13). The TSK-13 includes 13 items rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 13 to 52, with higher scores indicating greater fear of movement and higher levels of kinesiophobia.
Unit of Measure: TSK-13 total score (range 13-52)
Measured: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Jul 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rare Bone DisordersStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Sangiorgi, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102875
- Sponsor's protocol ID
- 363/2025/Sper/IOR
- Acronym
- PaS2-EXTEND
- Status last verified
- Mar 2026
- First submitted
- 14 Jul 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results will be made publicly available 6 months after publication of primary outcomes manuscript. Shared data will include demographic and baseline clinical characteristics; primary feasibility outcome data (recruitment, adherence, retention, adverse events); secondary outcome measures (IMU parameters, PRO scores) at all timepoints; group allocation; data dictionary defining all variables.
Publications
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Boarini M, Romeo A, Banchelli F, Grippa E, Forni S, la Forgia MC, Scognamiglio D, Ferraris PC, Sangiorgi L. Nature-based interventions for individuals with rare skeletal disorders: evaluation of a 5-day sailing program on health-related quality of life. Sci Rep. 2024 Nov 1;14(1):26339. doi: 10.1038/s41598-024-77934-1.
PubMed 39487306Cappelletti S, Tondo I, Pietrafusa N, Renzetti T, Pannacci I, Gentile S, Perrucci M, Calabrese C, Ferraris PC, Specchio N, Vigevano F. Improvement of quality of life in adolescents with epilepsy after an empowerment and sailing experience. Epilepsy Behav. 2020 May;106:106957. doi: 10.1016/j.yebeh.2020.106957. Epub 2020 Mar 16.
PubMed 32193096Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4.
PubMed 23245608Boarini M, Banchelli F, Scognamiglio D, Farella GM, Platano D, Rizzo S, Cavina U, Rogati G, Ramaglia Amadasi R, Villa G, Leardini A, Berti L, Sartini S, Magnanelli L, Locatelli A, Scopinaro AM, Sangiorgi L. Blended adapted sailing therapy with telerehabilitation for rare skeletal disorders: protocol for a pilot randomised controlled feasibility trial in Italy (PaS2-EXTEND). BMJ Open. 2026 May 18;16(5):e114628. doi: 10.1136/bmjopen-2025-114628.
PubMed 42150824
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study "Ready to Sail 2": Evaluation of the Feasibility and Safety of Sail-Assisted Telerehabilitation in Patients With Rare Skeletal Diseases - Assessment of Motor, Psychosocial, and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT07102875
- Acronym / sponsor ID
- PaS2-EXTEND / 363/2025/Sper/IOR
- Conditions
- Rare Bone Disorders
- Keywords
- Rare Diseases, Musculoskeletal Diseases, Telerehabilitation, Physical Therapy Modalities, Games, Recreational, Quality of Life, Feasibility Study, Social Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Ready to Sail 2 - EXTEND" is a pilot randomized interventional trial designed to assess the feasibility, safety, and preliminary impact of an innovative rehabilitation model combining sailing therapy (velatherapy) with a remote telerehabilitation maintenance program in young individuals with rare skeletal disorders. Building on the promising results of the previous Ready to Sail feasibility study (NCT06397443), this study aims to validate and compare two rehabilitative approaches.
A total of 24 patients aged 12-30 years with a confirmed diagnosis of a rare skeletal disorder will be randomly assigned (1:1) to either:
- Group 1 (Experimental): a 5-day intensive sailing therapy intervention followed by a 3-month personalized telerehabilitation program at home; or
- Group 2 (Active Control): a 3-month telerehabilitation-only program with identical frequency and progression.
The primary objective is to evaluate the feasibility of the experimental program, in terms of adherence, acceptability, and safety. Secondary outcomes include motor functionality (measured by inertial sensors), psychosocial well-being (assessed through validated PROMs), health-related quality of life, and pain perception. The study also explores the medium-term sustainability of rehabilitation outcomes and the influence of individual variables (e.g., age, gender, disease subtype).
The intervention is delivered through a multidisciplinary, patient-centered approach involving rare disease experts, physiatrists, biomechanical engineers, and partner sailing organizations. Sail training activities are adapted for safety and inclusion, and are conducted in two coastal settings (Marina di Ravenna and Palermo), ensuring geographical balance for participant accessibility.
This trial seeks to strengthen the evidence base for integrated, inclusive, and scalable rehabilitation models that address both motor and psychosocial dimensions in rare skeletal conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sailing Intervention Followed by Home-Based Telerehabilitation Program | Experimental | Behavioral: Sailing Intervention Plus Home-Based TelerehabilitationParticipants assigned to this arm will receive a 5-day intensive sailing intervention program, followed by a 3-month home-based telerehabilitation program. The sailing includes daily group-based sailing activities and debriefing activities aimed at enhancing motor skills, coordination, and psychosocial well-being. After the sailing phase, participants will engage in remote physical therapy sessions twice a week via a supervised digital platform. The telerehabilitation component includes progressive exercises targeting balance, proprioception, and functional strength. |
| Home-Based Telerehabilitation Program | Active comparator | Behavioral: Home-Based TelerehabilitationParticipants in this arm will undergo a 3-month home-based telerehabilitation program. The intervention consists of two weekly remote sessions conducted via an accredited digital platform. Each session includes warm-up, structured motor and postural exercises, and cool-down/stretching phases. Exercises are progressive and tailored to individual functional capacities, with the goal of improving balance, coordination, and physical function. No sailing therapy is included in this arm. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Individuals aged 12 to 30 years, of any sex
- Clinical and/or molecular genetic diagnosis of RSD per Orphanet classification
- No orthopedic surgery within the past 6 months, unless deemed clinically irrelevant to study participation by the investigator
- Ability to understand and comply with study procedures
- Signed informed consent obtained from the participant or a legal guardian (for minors)
Key exclusion criteria (7 listed)
- Severe or unstable medical conditions that could interfere with participation (e.g., uncontrolled cardiac or respiratory disease)
- Cognitive or neurological impairments that may hinder adherence to the study protocol
- Participation in similar intensive rehabilitation programs within the past 3 months
- Contraindications to virtual or sailing-based activities, including but not limited to: (a) Severe motion sickness; (b) Vertigo or vestibular disorders; (c) Photosensitive epilepsy
- Musculoskeletal injuries (e.g., fractures or major sprains) occurring within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sailing Intervention Plus Home-Based TelerehabilitationAlso: 5-day sailing activityA two-phase rehabilitation program combining 5 days of intensive sailing therapy with a 3-month home-based telerehabilitation plan. The sailing component includes group-based activities in adapted sailing environments, conducted in Marina di Ravenna or Palermo, with daily debriefing and psychosocial support. The telerehabilitation component includes twice-weekly supervised sessions delivered via a digital platform, focusing on progressive motor, proprioceptive, and postural exercises. The intervention aims to improve motor function, quality of life, and psychosocial well-being in individuals with rare skeletal disorders. | Behavioural | Sailing Intervention Followed by Home-Based Telerehabilitation Program |
| Home-Based TelerehabilitationParticipants perform a 3-month home-based rehabilitation program consisting of two remote sessions per week via a supervised digital platform. Each session includes warm-up, strength and coordination exercises, and cool-down. Exercises are progressive and standardized, but adapted to individual needs to ensure safety and adherence. The intervention targets motor function, balance, proprioception, and psychosocial outcomes, without any sailing component. This arm serves as the active comparator. | Behavioural | Home-Based Telerehabilitation Program |
Primary outcome
Adherence to Sailing and Home-Based Telerehabilitation
Time frame: At 6 months after baseline (end of intervention period)
Defined as the percentage of scheduled sessions completed by each participant. Adherence is considered achieved if ≥75% of scheduled sessions are completed. Unit of Measure: Percentage of participants meeting adherence threshold
Acceptability of the Intervention
Time frame: At 6 months after baseline (end of intervention period)
Defined by recruitment rate ≥80% and dropout rate <20%. Unit of Measure: Recruitment rate (%), Dropout rate (%)
Safety of the Intervention
Time frame: At 6 months after baseline (end of intervention period)
Defined as the absence of serious adverse events related to the intervention. Unit of Measure: Number of participants experiencing a serious adverse event
6 secondary outcomes
Change in Motor Function Measured by Inertial Measurement Units
Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Health-Related Quality of Life Measured by EQ-5D-5L
Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Psychosocial Functioning Measured by BESSI-45
Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Functional Outcomes Measured by PODCI
Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Change in Kinesiophobia Measured by Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 23295957Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Background: PubMed 39487306Boarini M, Romeo A, Banchelli F, Grippa E, Forni S, la Forgia MC, Scognamiglio D, Ferraris PC, Sangiorgi L. Nature-based interventions for individuals with rare skeletal disorders: evaluation of a 5-day sailing program on health-related quality of life. Sci Rep. 2024 Nov 1;14(1):26339. doi: 10.1038/s41598-024-77934-1.
- Background: PubMed 32193096Cappelletti S, Tondo I, Pietrafusa N, Renzetti T, Pannacci I, Gentile S, Perrucci M, Calabrese C, Ferraris PC, Specchio N, Vigevano F. Improvement of quality of life in adolescents with epilepsy after an empowerment and sailing experience. Epilepsy Behav. 2020 May;106:106957. doi: 10.1016/j.yebeh.2020.106957. Epub 2020 Mar 16.
- Background: PubMed 23245608Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4.
- Derived from this study: PubMed 42150824Boarini M, Banchelli F, Scognamiglio D, Farella GM, Platano D, Rizzo S, Cavina U, Rogati G, Ramaglia Amadasi R, Villa G, Leardini A, Berti L, Sartini S, Magnanelli L, Locatelli A, Scopinaro AM, Sangiorgi L. Blended adapted sailing therapy with telerehabilitation for rare skeletal disorders: protocol for a pilot randomised controlled feasibility trial in Italy (PaS2-EXTEND). BMJ Open. 2026 May 18;16(5):e114628. doi: 10.1136/bmjopen-2025-114628.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results will be made publicly available 6 months after publication of primary outcomes manuscript. Shared data will include demographic and baseline clinical characteristics; primary feasibility outcome data (recruitment, adherence, retention, adverse events); secondary outcome measures (IMU parameters, PRO scores) at all timepoints; group allocation; data dictionary defining all variables.
Related trials for Rare Bone Disorders
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingObservational study
Natural History, Pathogenesis and Outcome of Melorheostosis A Rare Osteosclerotic Disease
Rheumatic Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sailing Intervention Plus Home-Based Telerehabilitation and Home-Based Telerehabilitation in people with Rare Bone Disorders, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Sailing and Home-Based Telerehabilitation (time frame: At 6 months after baseline (end of intervention period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07102875, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.